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Topoisomerase I inhibitors

Lurbinectedin for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by PharmaMar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 66 months

Awards & highlights

Study Summary

This trial is testing a new cancer drug, Lurbinectedin, in combination with another cancer drug, irinotecan. The trial will have two parts: first, they will test different doses of the drugs to see what is safe; then, they will expand the trial to include more people.

Who is the study for?

Adults with certain advanced solid tumors who've had a break from cancer treatments for at least three weeks, are in fairly good health (ECOG ≤ 1), and have a life expectancy of over three months. They must not be pregnant or breastfeeding and should use effective contraception. Excluded are those with active COVID-19, prior significant bone marrow treatments, known brain metastases, or allergies to study drugs.Check my eligibility

What is being tested?

This is an early-phase trial testing the combination of two cancer drugs: Lurbinectedin and Irinotecan. It's divided into two parts: first finding the right doses (Phase I) and then expanding to more patients at that dose (Phase II).See study design

What are the potential side effects?

Possible side effects include reactions related to drug infusion, fatigue, digestive issues like nausea and diarrhea, lowered blood cell counts leading to increased infection risk or bleeding problems, liver function changes, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 66 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~66 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 66 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD)

Recommended Dose (RD)

Response Rate

Secondary outcome measures

Area under the plasma concentration versus time curve (AUC)

Clearance (CL)

Duration of response

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Lurbinectedin Escalation GroupExperimental Treatment2 Interventions

Irinotecan 75 mg/m^2 as a 90-min (-5-min/+30-min) intravenous (i.v.) infusion, followed by Lurbinectedin with starting dose of 1.0 mg/m^2 as a 60-min (-5-min/+20-min) i.v. infusion followed by Irinotecan alone on Day 8 (at the same dose as Day 1 and as a 90-min [-5-min/+30-min] i.v. infusion)

Group II: Irinotecan Escalation GroupExperimental Treatment2 Interventions

Starting dose of Irinotecan 15 mg/m^2 as a 90-min (-5-min/+30-min) i.v. infusion, followed by Lurbinectedin 3.0 mg/m^2 as a 60-min (-5-min/+20-min) i.v. infusion followed by Irinotecan alone on Day 8 (at the same dose as Day 1 and as a 90-min [-5-min/+30-min] i.v. infusion).

Group III: Intermediate Escalation GroupExperimental Treatment2 Interventions

Starting dose of Irinotecan 50 mg/m^2 as a 90-min (-5-min/+30-min) i.v. infusion, followed by Lurbinectedin 2.6 mg/m^2 as a 60-min (-5-min/+20-min) i.v. infusion. No Irinotecan dose will be administered on Day 8 in this group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan

2017

Completed Phase 4

~2680

Lurbinectedin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PharmaMarLead Sponsor

90 Previous Clinical Trials

11,217 Total Patients Enrolled

Media Library

Irinotecan (Topoisomerase I inhibitors) Clinical Trial Eligibility Overview. Trial Name: NCT02611024 — Phase 1 & 2

Solid Tumors Research Study Groups: Intermediate Escalation Group, Lurbinectedin Escalation Group, Irinotecan Escalation Group

Solid Tumors Clinical Trial 2023: Irinotecan Highlights & Side Effects. Trial Name: NCT02611024 — Phase 1 & 2

Irinotecan (Topoisomerase I inhibitors) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02611024 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would it be possible to join this clinical trial?

"The data available on clinicaltrials.gov suggests that this trial is still enrolling patients. The original posting date was May 6th, 2016 and the most recent update was November 26th, 2021."

Answered by AI

What is the previous research on Lurbinectedin's efficacy?

"There are a total of 283 Lurbinectedin studies currently underway, 54 of which are Phase 3 trials. The majority of these active studies are based in Woolloongabba, Queensland; however, there are 8,831 clinical locations running these types of tests worldwide."

Answered by AI

What indications does Lurbinectedin commonly address?

"Lurbinectedin is a medication that oncologists often prescribe to patients with colorectal carcinoma. Additionally, it can be effective in treating ovarian cancer, sarcoma, and metastatic colorectal carcinoma."

Answered by AI

How many participants are needed for this clinical trial?

"That is correct. The online information on clinicaltrials.gov affirms that this study, which was first advertised on May 6th 2016, is recruiting patients at this time. They are currently looking for 320 individuals total from two different locations."

Answered by AI

Why did researchers design this clinical study in this way?

"As stated by the study's sponsor, PharmaMar, the primary goal of this trial is to establish the Maximum Tolerated Dose (MTD) over a 66-month period. Additionally, secondary objectives include evaluating antitumor response, half-life, and clearance."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors

2016. "Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02611024.

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